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FDA Releases Guidance for Acceptance of clinical Data from trials outside the USA

New Guidance issued by FDA for sponsors of medical devices who want to use their clinical data from trials outside the US for an FDA submission

This is a new draft policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States.